Implantable device and programmer system which permits multiple programmers

ABSTRACT

A multiprogrammer system, for monitoring and optimizing implant performance, includes at least two programmers and an implant. Each programmer may perform inquiry and programming operations on the implant. In an inquiry operation, the programmer retrieves some or all of the configuration parameters from the implant. In a programming operation, the programmer provides one or more modified parameters to the implant. As part of the programming operation, the programmer is configured to verify that it is aware of the implant&#39;s current parameters before sending modified parameters. The current programmer verifies that the implant&#39;s parameters have not been altered since the current programmer&#39;s last interaction with the implant. If the parameters have been altered, the current programmer aborts the programming operation and provides notification. The verification may be performed by the implant, i.e., it may verify that the programmer is aware of the current device parameters before the implant accepts modified parameters.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to programming of implantable devices,and more particularly to a programming system which addresses thedangers raised by the presence of multiple programming devices.

2. Description of the Related Art

Implantable devices have become a standard method of treating variousmedical conditions, many of which relate to the heart. Examples ofimplantable devices include pacemakers, defibrillators, nervestimulators, drug delivery devices, and implanted personalidentification chips. Many types of implantable devices are availablewith high capacity memories for storing data and various programmableconfiguration parameters. In the case of medical devices, the data to bestored may include physiological data such as the electrogram(electrical waveform of the heart detected at the electrodes),instantaneous heart rate, blood pressure, volume pumped, bodytemperature, etc. Configuration parameters that are stored may includemodes of operation, amplifier sensitivity, filter bandwidth, adaptationalgorithms, output voltages, currents and pulse widths, blankingperiods, various pacing rates, circadian response patterns, leadcharacteristics, delay intervals, detection thresholds, safety margins,logging criteria, and error messages. As implantable devices increase insophistication, the number of configuration parameters is also expectedto increase.

Referring now to FIG. 1, a human torso 102 is shown having animplantable device 106 coupled to a heart 104. When a wand 108 from anexternal programming device 110 is placed in proximity to implantabledevice 106, the programming device 110 can establish two-waycommunication with implantable device 106 to retrieve data and toprovide new configuration parameters. Often the device 106 collects dataover a period of hours or days. In the case of a pacemaker, the data mayrepresent measured physiological signals such as cardiac voltages (EKGsignals), blood temperatures, oxygen levels, sugar levels, and otherphysical parameters.

Illustratively, the programming device 110 comprises an implantabledevice programmer and data analyzer that is used by a physician. Theprogrammer/analyzer operates to download information stored inimplantable device 106 by transmitting signals which place the pacer ina mode for downloading, and thereafter detecting signals sent by thedevice. Then, under control of the physician or other medicalprofessional, the programmer/analyzer operates to analyze and displaythe information in a format which allows the physician to diagnose anyproblems. After performing an analysis, the physician may instruct theprogrammer/analyzer to adjust operating parameters for a different modeof operation, sensitivity setting, or other parameter value, to tailorthe behavior of the device to the patient and thereby optimize thepatient's quality of life. If this is the case, the programmer/analyzer110 provides new operating parameters to the implantable device 106.

Implant manufacturers have long been aware of a danger known as the“multiple programmer” problem which can result in an implantable devicehaving incorrect and perhaps even dangerous or harmful configurationparameters. The following scenario is presented to illustrate thisproblem.

A patient with an implantable device enters an examination room, and aspart of a routine initial examination has a medical technician use afirst programming device “A” to download data and configurationparameters from the implantable device. Depending on the amount of dataand the baud rate of the device, the download time may range from 20seconds to 20 minutes. In the absence of any gross abnormalities in thedownloaded data, the patient is sent to another room for an exercisesession to determine “rate modulated” settings, i.e. configurationparameters for adjusting the pacemaker pace rate in response todetecting patient exertion. In this room, a physician uses a secondprogramming device “B” to download and adjust the configurationparameters in response to the results of the exercise session.Programming device “B” is used to reprogram the implantable device withthe adjusted parameters. The patient then returns to the examinationroom, where a physician uses programming device “A” to adjust some ofthe configuration parameters in response to analysis of the downloadeddata. Programming device “A” is then used to reprogram the implantabledevice with the adjusted parameters. It is important to note'thatprogramming device “A” is, at this point, operating with an obsoleteversion of the implant's configuration settings. This situation occurswhenever changes are made to the implantable device's configurationparameters by a second programming device “B” between the download andreprogramming operations of the first programming device “A”.

The configuration parameters of an implantable device such as apacemaker can individually be set to typical values within a normaloperating range, but the programming device must still check forincompatible parameter settings to avoid dangerous combinations ofparameter values. For example, programming an inappropriately longrefractory period in conjunction with a short pacing cycle may lead tounpredictable pacing behavior. If a programming device with an obsoleteversion of the implant device's configuration settings reprograms only afew parameters, any safeguards that the programming device implements toavoid incompatible parameter settings could be unintentionallycircumvented.

One programmer safeguard that has been employed is to have programmingdevice “A” reprogram the implantable device with a complete set ofconfiguration parameters rather than just the parameters which have beenadjusted. Although this successfully prevents incompatible configurationsettings, the previous adjustments are completely undone without anyindication to the physician. Further, the reprogramming time isunnecessarily increased beyond what may be strictly necessary.

The solution commonly employed by implant manufacturers has been simplyto issue warnings regarding the danger of using multiple programmingdevices. A more effective and inexpensive solution to the multipleprogramming device problem is desirable.

SUMMARY OF THE INVENTION

Accordingly, there is provided herein a multiprogrammer system formonitoring and optimizing implantable device performance. In oneembodiment, the system includes at least two programming devices and animplantable device. Each of the programming devices may be used toperform inquiry and programming operations on the implantable device. Inan inquiry operation, the programming device retrieves some or all ofthe configuration parameters from the implantable device. In aprogramming operation, the programming device provides one or moremodified parameters to the implantable device. As part of theprogramming operation, the programming device is configured to verifythat it is aware of the implantable device's current parameters beforesending the modified parameters. In other words, the current programmingdevice verifies that the implantable device's parameters have not beenaltered by another programming device since the current programmingdevice's last interaction with the implantable device. If the parametershave been altered, the current programming device aborts the programmingoperation and notifies the operator. In alternate embodiments, theverification may be performed by the implantable device, i.e. theimplantable device may verify that the programming device is aware ofthe current device parameters before the implantable device accepts themodified parameters.

As part of the multiprogrammer system provided herein, there isdisclosed a programming device embodiment, an implantable deviceembodiment, and various methods for verifying that the programmingdevice has been provided with a current version of the implantabledevice's configuration parameters. The programming device preferablycomprises a user interface, a memory, a communications circuit, and amicroprocessor. The communications circuit generally includes acommunication coil, receive sensor, modulator, and demodulator, and isconfigurable to send and receive configuration parameters to and fromthe implantable device. The microprocessor couples to the userinterface, the memory, and the communications circuit, and it operatesunder control of the user interface to retrieve configuration parametersfrom the implantable device and to store the parameters in memory. Theconfiguration parameters may be modified, and the modified parameterscan be sent to the implantable device. In certain disclosed embodiments,the microprocessor uses one of the following methods to verify that thestored configuration parameters are “current” before sending themodified parameters, that is, the microprocessor verifies that theimplantable device's parameters have not been altered .since thisprogrammable device last retrieved the implantable device's parameters.

The implantable device comprises a microprocessor coupled to a memoryand a telemetry module. The memory stores configuration parameters, andthe telemetry module transmits and receives external communications. Themicroprocessor performs some algorithm in a manner governed by theconfiguration parameters stored in the memory. In certain disclosedembodiments, the microprocessor uses one of the following methods toverify that an external programming device has received a currentversion of the configuration parameters before accepting modifiedconfiguration parameters from the programming device.

The disclosed methods for verifying that a programming device is awareof the implantable device's current configuration parameters include:(1) providing a programming device serial number to the implantabledevice as part of every inquiry operation; (2) allowing a programmingoperation only within a predetermined time interval after an inquiryoperation; (3) storing the date and time of the most recent inquiryoperation; (4) storing the date and time of the most recent programmingoperation; and (5) retrieving the implantable device's currentparameters as part of every programming operation. For method (1), theimplantable device or the programming device can be configured tocompare the programming device's serial number with the serial number ofthe last programming device to retrieve the implantable device'sconfiguration parameters. A match indicates that the programming deviceis aware of the implantable device's current parameter values.

For method (2), the implantable device or the programming device candetermine if the downloaded version of the configuration parameters has“expired”, that is, whether a predetermined amount of time has passedsince the configuration parameters were last retrieved. For method (3),the implantable device or programming device can be configured tocompare the date and time of the most recent inquiry stored in theprogramming device to that stored in the implantable device. A matchindicates that the programming device is aware of the implantabledevice's current parameter values.

Similarly, for method (4), the implantable device or programming devicecan be configured to compare the date and time of the most recentprogramming operation stored in the programming device to that stored inthe implantable device. Finally, for method (5), the programming devicecan be configured to retrieve the implantable device's configurationparameters immediately prior to a programing operation to verify thatthe programming device has a current version. These methods will bedescribed in more detail further below.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects and advantages of the invention will become apparent uponreading the following detailed description and upon reference to theaccompanying drawings in which:

FIG. 1 shows an implantable medical device and a programming device;

FIG. 2 is a block diagram of an implantable pacemaker;

FIG. 3 is a block diagram of an exemplary embodiment of a programmingdevice;

FIG. 4 is a flowchart depicting a method for performing inquiry andprogramming operations;

FIG. 5 is a flowchart illustrating the multiprogrammer problem;

FIG. 6 is a flowchart depicting a first method for performing inquiryand programming operations in a multiprogrammer environment;

FIG. 7 is a flowchart depicting a second method for performing inquiryand programming operations in a multiprogrammer environment;

FIG. 8 is a flowchart depicting a third method for performing inquiryand programming operations in a multiprogrammer environment;

FIG. 9 is a flowchart depicting a fourth method for performing inquiryand programming operations in a multiprogrammer environment;

FIG. 10 is a flowchart depicting a fifth method for performing inquiryand programming operations in a multiprogrammer environment;

FIG. 11 is a flowchart depicting a sixth method for performing inquiryand programming operations in a multiprogrammer environment;

FIG. 12 is a flowchart depicting a seventh method for performing inquiryand programming operations in a multiprogrammer environment;

FIG. 13 is a flowchart depicting an eighth method for performing inquiryand programming operations in a multiprogrammer environment; and

FIG. 14 is a flowchart depicting a ninth method for performing inquiryand programming operations in a multiprogrammer environment.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof are shown by way ofexamples in the drawings and will herein be described in detail. Itshould be understood, however, that the drawings and detaileddescription thereto are not intended to limit the invention to theparticular form disclosed, but on the contrary, the intention is tocover all modifications, equivalents and alternatives falling within thespirit and scope of the present invention as defined by the appendedclaims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description illustrates the principles of the presentinvention with respect to an implantable pacemaker (“pacer”) and aprogramming device (“programmer”). The invention, however, is directedto a system for permitting multiple programming devices to interact withan implantable device. Thus, the invention applies to implantablecardioverter/defibrillators (ICD's), nerve stimulators, drug deliverydevices, or any other implantable device which may have programmableconfiguration parameters set by a programming device.

Referring now to FIG. 2, an exemplary implantable device 106 (such as apacemaker) preferably includes a power supply 202 coupled to amicroprocessor 204. The power supply 202 provides power to all thedevices shown in FIG. 2 through connections which are not specificallyshown. In the exemplary embodiment, the microprocessor 204 couples to amemory 206, a first interval timer 208, and a second interval timer 210via an I/O (input/output) bus 211. The microprocessor 204 also couplesto control an atrium sensor/stimulator 212 and a ventriclesensor/stimulator 214, each of which may be coupled to the heart byflexible leads. Finally, microprocessor 204 couples to a telemetrymodule 218 to communicate with programming device 110.

The microprocessor 204 preferably is programmable and operates accordingto a program stored preferably in a nonvolatile memory such as aread-only memory (not specifically shown). The program isparameterized—i.e. one or more of the operations the microprocessorperforms is alterable by setting a configuration parameter. For example,the microprocessor may be programmed to periodically trigger the atriumsensor/stimulator 212 to deliver a pulse to the heart 104. In thisinstance, one of the configuration parameters for this operation is themaximum trigger delay, that is, a value specifying the maximum timedelay before the atrium stimulator is triggered. The maximum triggerdelay, along with other configuration parameters, is provided tomicroprocessor 204 via telemetry module 218 and stored in memory 206.During pacemaker operation, the microprocessor 204 retrieves the maximumtrigger delay from the memory 206 and uses it to set interval timer 210after each triggering of the atrium sensor/stimulator. If the intervaltimer 208 expires, the microprocessor then triggers atriumsensor/stimulator 212.

Referring still to FIG. 2, the first interval timer 208 determines thedelay between trigger signals applied to atrium stimulator 212 andventricle stimulator 214. The second interval timer 210 measures thetime since the last heartbeat sensed by the atrium sensor/stimulator 212or ventricle sensor/stimulator 214. When either timer elapses, theelapsed timer asserts an interrupt signal to microprocessor 204 tonotify the microprocessor 204 that the set amount of time has passed.Microprocessor 204 determines the source of the interrupt according toconventional techniques and takes the appropriate action. For example,if the maximum trigger delay (interval timer 210) has elapsed since thelast heartbeat, the microprocessor 204 triggers atrium sensor/stimulator212.

The microprocessor 204 also preferably monitors one or morephysiological signals. In the pacemaker example, the microprocessor 204detects cardiac voltage signals via atrium sensor 212 and/or ventriclesensor 214. The heart leads which provide electrical pulses to the heartmay also be used to sense electrical signals created by the heart as itbeats, and these signals are used by the microprocessor 204 to adjustthe timing of the electrical pulses. When other sensors are coupled tothe implantable device 106, the microprocessor can also monitor bloodpressure, body temperature, oxygen levels, and other physiologicalparameters. The microprocessor 204 can also track its own performance,perhaps by logging the manner in which adaptation is performed on theparameters. The physiological signals and performance information can belogged in memory 206 for later retrieval by programming device 110. Thememory 206 preferably is large enough to store data regarding severalphysiological signals that being are monitored over a period of severaldays. Memory 206 preferably is implemented as dynamic random accessmemory (DRAM) or other suitable memory type.

The atrium sensor/stimulator 212 is an interface circuit betweenmicroprocessor 204 and a heart lead coupled to an atrium of the heart.An interface circuit is necessary to allow the digital, low voltagemicroprocessor to control the high-energy pulses delivered to the heart,and additionally, to allow the microprocessor to monitor the analogelectrical signals that are generated by the heart as it beats.Similarly, the ventricle sensor/stimulator 214 is an interface circuitbetween microprocessor 204 and a heart lead that couples to a ventricleof the heart. When atrium sensor/stimulator 212 receives a triggersignal from microprocessor 204, it generates a shaped electrical energypulse to the atrium. Likewise, when ventricle sensor/stimulator 212receives a trigger signal from microprocessor 204, it provides a shapedelectrical energy pulse to the ventricle. If the microprocessor is usingatrium sensor/stimulator 212 or ventricle sensor/stimulator 214 tomeasure cardiac voltage signals from the electrodes to monitor theperformance of the heart, the microprocessor 204 stores the cardiacwaveforms (or “electrograms”) in memory for subsequent retrieval by amedical technician.

Telemetry module 218 may be designed to be activated by programmingdevice 110 when wand 108 enters into proximity with pacer 106. Forexample, the telemetry module 218 may continually be checking for anactivation signal that the wand 108 transmits. Activation of thetelemetry module 218 causes the telemetry module 218 to establishbidirectional communication with wand 108 and to notify microprocessor204 of an incoming communication. As the wand 108 transmits a messagesignal, the telemetry module demodulates the message signal and deliversthe incoming message to the microprocessor 204. The microprocessor 204decodes the incoming message and stores any received data or parameters.In addition, the microprocessor 204 responds to any received commandsfrom the programming device 110. For example, one command might be an“inquiry”, that is, a request for the microprocessor 204 to transferconfiguration parameters from memory 206 to programming device 110. Inthis case, microprocessor 204 provides the configuration parameters frommemory 206 to telemetry module 218 for transferal to programming device110.

Referring now to FIG. 3, programming device 110 includes amicroprocessor 302, a modulator 304 coupled to a transmit coil 306, ademodulator 310 coupled to a receive sensor 308, a memory 312, and auser interface 314. The microprocessor 302 responds to user input viathe user interface 314 (which may comprise a graphic display and userinput device such as a keypad) and initiates communications with pacer106 (FIG. 2). For example, if a user requests a download of data fromthe pacer to programming device 110, microprocessor 302 formulates acommand signal, and sends the signal to modulator 304. Modulator 304converts the command signal into a modulated signal for driving transmitcoil 306. The signal driving the transmit coil 306 produces a changingmagnetic field which induces a current in a receive coil in the pacer.The pacer processes the induced current to reconstruct the informationsent from the programming device, and formulates and sends a reply. Thepacer can transmit signals to programming device 110 by various meansincluding modulating a light signal or driving a transmit coil. Receivesensor 308 detects and amplifies the signal transmitted by the pacer toproduce a detection signal. Demodulator 310 demodulates the detectionsignal and converts it into the data transmitted by the pacer 106.Demodulator 310 then provides the data to microprocessor 302 foreventual analysis and display via user interface 314. Memory 312 may beused to store data and configuration parameters downloaded from thepacer.

Referring now to FIG. 4, a pair of flowcharts are provided to illustratethe operation of the processor 302 in the programming device 110 and theoperation of the processor in 204 the implantable device 106 during theinquiry and programming operations. The programming device's processor302 starts in step 401 and the implantable device's processor 204 startsin step 411. In step 402 the processor 302 initiates an inquiryoperation by sending a command to the implantable device requesting theimplantable device to transmit its model and serial number. In step 403the processor 302 receives the model and serial number information andstores it for future identification of the implantable device. In step404 the processor 302 sends a request to the implantable device for theimplantable device to transmit one or more of its configurationparameters. The parameter request may be a partial request, in whichonly certain specified parameters are requested, or a full request, inwhich a download of all the configuration parameters is requested. In atypical initial inquiry operation, the parameter request is a fullrequest. In step 405 the processor 302 receives the transmittedconfiguration parameters and stores them in memory for analysis andpossible alteration by the user of the programming device 110. This maycomplete the inquiry operation, or as a further part of the inquiryoperation the processor 302 may request and receive stored physiologicaldata from the implantable device.

After a user examines the configuration parameters and analyzes anydownloaded data, the user may wish to modify one or more of theconfiguration parameters and to perform a programming operation toreprogram the implantable device with the modified parameters. In step406 the processor 302 initiates a programming operation by sending acommand to the implantable device requesting the implantable device totransmit its model and serial number. In step 407 the processor 302receives the model and serial number information and verifies that itmatches with the stored identification information from step 403. Theprocessor then in step 408 transmits the modified parameters. Theprogramming device transmits a partial or complete parameter set to theimplantable device. A partial parameter set is preferred for a fasterprogramming operation, but a complete parameter set is preferred foradded safety against incompatible configuration parameter settings. Instep 409 the processor 302 receives confirmation from the implantabledevice that the transmitted parameters were successfully received. Ifconfirmation is not received, in step 409, then the user is notified ofa failure to reprogram the implantable device. The processor 302completes the programming operation by entering into end state 410.

In step 412 processor 204 of the implantable device receives the modeland serial number request command sent by the programming device in step402. In step 413 the processor 204 responds by transmitting the modeland serial number of the implantable device. In step 414 the processor204 receives the configuration parameter request command from theprogramming device, and in step 415 the processor responds bytransmitting the current configuration parameter values. Subsequentlyduring a programming operation, the processor 204 receives another modeland serial number request command in step 416, and responds in step 417by transmitting the model and serial number of the implantable device.Then in step 418 the processor 204 receives modified parameter valuesfrom the programming device. After verifying that the parameters havebeen correctly received, the processor updates the configurationparameters with the new values and, in step 419, transmits aconfirmation message to the programming device.

FIG. 5 illustrates how the use of multiple programming devices canintroduce safety concerns when a second programming device interactswith an implantable device between the inquiry and programmingoperations of the first programming device. An implantable device beginsin step 502. In step 504, an inquiry operation is performed by a firstprogramming device “A”. Subsequently, a second programming device “B”performs an inquiry operation on the implantable device in step 506, anda programming operation on the implantable device in step 508. The firstprogramming device “A” is then used to program the implantable device instep 510, and at the end of this sequence in step 512, the implantabledevice may be left with an undesired set of configuration parameters. Toavoid this, programming device “A” or the implantable device may beprovided with a means for detecting if another programming deviceinteracted with the implantable device between the inquiry and programoperations of programming device “A”.

A first embodiment of a multiple programming device-implantable devicesystem is shown in FIG. 6. The programming device's processor 302proceeds through the inquiry operation steps 401-405 as outlinedpreviously. After the processor 302 successfully receives all therequested parameters in step 405, in step 601 the processor 302 sends aprogramming device identification number to the implantable device forthe implantable device to store. The programming device identificationnumber preferably includes the model number and serial number of theprogramming device. In this system embodiment, the implantable devicealways has a record of the last programming device to successfullyperform an inquiry or programming operation on it.

Subsequently, when the programming device is ready to transmit alteredparameters to the implantable device, the processor 302 proceeds throughsteps 406, 407, and after verifying that the implant identificationinformation matches, the processor transmits the programming deviceidentification number in step 602 before transmitting the modifiedconfiguration parameters in step 408 and proceeding through steps 409and 410.

The implantable device's processor 204 similarly proceeds throughinquiry operation steps 411-415 as outlined previously. After theprocessor 204 transmits the requested parameters in step 415, itreceives and stores the programming device identification information instep 603. Then when the programming device initiates a programmingoperation, the processor 204 performs steps 416, 417 before receivingthe programming device's identification information in step 604. In step606 the processor 204 compares the received identification informationto the previously stored identification information from step 603. Ifthey do not match, then in step 608 the processor 204 transmits a denialto the programming device and ends the programming operation in step420. If the information matches, then the processor 204 performs steps418-420 to accept and confirm the modified parameters.

This system embodiment provides that only the programming device whichhas most recently interacted successfully with the implantable device isallowed to program the implantable device. Referring back to FIG. 5, instep 510 this embodiment of programming device “A” would receive adenial from the implantable device when a programming operation isattempted. Programming device “A” would preferably inform the user ofthe denial and allow the user to initiate an inquiry operation todiscover any alterations which may have been made to the configurationparameters.

Another system embodiment is illustrated in FIG. 7. The inquiryoperation of this embodiment matches that of the previous embodiment forboth the programming device and the implantable device. After step 417of the programming operation, the implantable device's processor 204sends the programmer identification information to the programmer devicein step 705. Then in step 418, the processor 204 receives anytransmitted parameters and proceeds through steps 419, 420 as outlinedpreviously.

After step 407 of the programming operation the programming device'sprocessor 302 receives in step 701 the identification information of thelast programmer to interact with the implantable device. In step 703 theprocessor 302 verifies that the identification information matches theprogramming device's model and serial number. If they do not match, theprocessor 302 terminates the programming operation in step 410 andpreferably notifies the user of the error. Otherwise, the processorproceeds through steps 408-410 of the programming operation to providethe modified parameters to the implantable device. This embodimentadvantageously places fewer demands on the implantable device, therebyminimizing implementation cost.

Another programming device embodiment is shown in FIG. 8. In thisembodiment, after successfully receiving the configuration parameters instep 405, the programming device's processor 302 starts a timer in step801. Subsequently, before initiating a transmission of alteredparameters, the processor 302 checks for expiration of the timer in step803. If too much time has elapsed, the processor 302 aborts theprogramming operation and preferably notifies the operator. Otherwise,the processor 302 continues with the programming operation in steps406-410. An implantable device embodiment which operates similarly isshown in FIG. 9. After successfully completing transmission of requestedparameters, the implantable device's processor 204 starts a timer instep 902. After a programming operation is initiated, the processor 204checks for expiration of the timer in step 904. If too much time haselapsed, the processor 204 transmits a denial in step 906, and theprogramming device preferably notifies the operator of the failure ofthe programming operation. Otherwise, the processor 204 continues theprogramming operation in steps 418-420. In a variation on theembodiments of FIGS. 8 and 9, the timers may be restarted aftersuccessful completion of the programming operation. The timers in FIGS.8 and 9 preferably run for a time period greater than 5 minutes and lessthan 60 minutes. A time period of between 10 and 20 minutes iscontemplated.

Two more system embodiments are shown in FIGS. 10 and 11. Theseembodiments are closely related to those of FIGS. 6 and 7, respectively.However, rather than using the programming device's identificationnumber to identify the programming devices, these embodiments use thetime and date of last access to identify the programming devices.

Referring now to FIG. 10, after the programming device's processor 302successfully receives all the requested parameters in step 405, in step1001 the processor 302 stores and sends a current time and date to theimplantable device for the implantable device to keep on record.Subsequently, when the processor 302 is instructed to send alteredparameters to the implantable device, the processor 302 performs steps406, 407 and then in step 1002 transmits the stored time and date to theimplantable device before proceeding with the remaining steps 408-410.

The implantable device's processor 204 performs steps 411-415 of theinquiry operation and in step 1003 receives and stores the date and timetransmitted by the programming device. In the subsequent programmingoperation the processor 204 performs steps 416, 417 before receiving thetransmitted time and date from the programming device in step 1004. Thenin step 1006 the processor 204 compares the transmitted time and date tothe stored time and date at which the last programming devicesuccessfully inquired or programmed the implantable device. If thenumbers do not match, the processor 204 transmits a denial to theprogramming device in step 1008. Otherwise the processor 204 proceeds toreceive the new parameters in step 418. Upon successful reception of allthe transmitted parameters, the processor 204 sends a confirm signal instep 419 and stores the new parameters.

Referring now to FIG. 11, the inquiry operations of both the programmingdevice and implantable device are the same as those of FIG. 10. In step1105, the implantable device's processor 204 sends the stored date andtime after establishing the implantable device's identity in steps416-417, and before performing the remaining programming steps 418-420.After steps 406-407 of the programming operation, the programmingdevice's processor 302 receives the date and time of last successfulinquiry operation from the implantable device in step 1101. In step1103, the processor 302 compares the received date and time to its ownstored date and time of last successful operation to determine if anyother programming device has successfully interacted with theimplantable device since the current programming device's last inquiryoperation. If the access date and times are the same, the processor 302proceeds with steps 408-410 of the programming operation. Otherwise, theprocessor 302 terminates the program operation in step 410 andpreferably notifies the user of the error.

A preferred system embodiment is shown in FIG. 12. In this embodiment, atime and date is associated with the last successful programming of theimplantable device 106. After the programming device's processor 302performs steps 401-405 of the inquiry operation, in step 1201 itreceives and stores the time and date of the last programming operationon the implantable device. In any subsequent programming operation, theprocessor 302 establishes the identity of the implantable device insteps 406-407 and sends the stored time and date in step 1202 beforesending any parameters in step 408. After transmitting the parameters,the processor 302 sends the current date and time to the implantabledevice. The processor 302 then completes the programming operation steps409-410.

After the implantable device's processor 204 performs inquiry operationsteps 411-415, it sends the time and date of the last programmingoperation in step 1204. In the subsequent programming operation, theprocessor 204 establishes the implant's identity to the programmingdevice in steps 416-417. In step 1205, the processor 204 receives theprogramming device's record of the last programming date and time, andcompares it with the implantable device's record of the last programmingdate and time in step 1206. If they do not match, then the implantabledevice has been reprogrammed since the last inquiry operation by theprogramming device, and the processor 204 transmits a denial in step1208 and terminates the programming operation in step 420. Otherwise,the is processor 204 accepts the new parameters in step 418, and thecurrent date and time in step 1210. If the programming operation issuccessful, the implantable device stores the current date and time asthe new programming date and time, and in step 419 sends a confirmationto the programming device.

A more preferred embodiment is shown in FIG. 13. The inquiry operationis the same as the inquiry operation of the embodiment shown in FIG. 12.The programming operation differs for the implantable device in thatafter transmitting its identification information in step 417, theprocessor 204 transmits the stored programming date and time to theprogramming device in step 1305. The processor 204 then accepts anytransmitted modified parameters in step 418 and if the transmission issuccessful, accepts and stores the current date and time in step 1210before sending a confirmation in step 419.

The programming operation for the programming device begins with theprocessor 302 requesting and receiving the implantable device'sidentification information in steps 406-407. In step 1301 the processorreceives the transmitted date and time from the implantable device andin step 1303 compares the transmitted date and time to the storedprogramming date and time. If they match, then none of the configurationparameters has been re-programmed since the programming device's lastinquiry operation. Consequently, the processor 302 proceeds to send thenew parameters in step 408 and the current date and time in step 1203.Otherwise, the programming device ends the program operation in step 410and preferably notifies the operator of the error.

The embodiments of FIGS. 12 and 13 are preferred relative to thepreviously described embodiments since in these embodiments, multipleprogramming devices can simultaneously be qualified to provide a new setof parameters to the implantable device. Any programming device with acurrent version of the configuration parameters (as indicated by theassociated programming date and time) can successfully program theimplantable device. Conversely, in the other previously describedembodiments, only a single programming device at a time (the one whichhas most recently interacted with the implantable device) cansuccessfully program the implantable device.

Referring now to FIG. 14, yet another embodiment is shown. In thisembodiment, prior to each programming operation, programming device 110inquires the configuration parameters in order to verify the accuracy ofprogramming device 110's copy of those parameters. The inquiryoperations for the implantable device and the programming device is thesame as that of FIG. 4. For the programming operation, the implantabledevice's processor 204 performs steps 416-417 to establish its identityto the programming device. Then in step 1406 the processor 204 receivesa parameter request similar to that of step 414, and in step 1407responds to the parameter request by sending the requested parameters.Then in step 418 the processor 204 may receive modified parameters fromthe programming device, and in step 419 the processor 204 acknowledges asuccessful receipt of the parameters and updates the current parameterswith the new parameter values.

The programming device's processor 302 performs steps 406-407 toestablish the implantable device's identity, then in step 1401, theprocessor 302 transmits a request for the configuration parameterssimilar to that of step 404. The processor 302 receives the transmittedparameters in step 1403 and in step 1405 compares them with theparameters from the previous inquiry. If there is no change (or only aslight change which may be attributed to adaptation or progression of aprogrammed algorithm), then the implantable device has not beenreprogrammed since the inquiry. The processor 302 consequently transmitsthe new configuration parameters in step 408. Otherwise, the programmingdevice terminates the programming operation in step 410 and preferablynotifies the user of the failure.

Numerous variations and modifications will become apparent to thoseskilled in the art once the above disclosure is fully appreciated. It isintended that the following claims be interpreted to embrace all suchvariations and modifications.

1-43. (Canceled)
 44. A method, comprising: programming parameters in amedical implant; determining if the parameters have been altered sincethe programming parameters; modifying the parameters if the parametershave not been altered; and halting modifying the parameters if theparameters have been altered.
 45. The method of claim 44, whereinprogramming parameters includes programming the parameters with aprogrammer, and wherein halting modifying the parameters includesnotifying an operator that the programmer was not a last device tointeract with the medical implant.
 46. The method of claim 44, whereinprogramming parameters includes programming the parameters with a firstprogrammer and subsequently altering the parameters with a secondprogrammer.
 47. The method of claim 46, wherein modifying the parametersincludes modifying the parameters with the second programmer.
 48. Themethod of claim 46, wherein halting modifying the parameters includeshalting modifying the parameters when modification is attempted usingthe first programmer. 49-57. (Canceled)
 58. A method, comprising:storing a program in an implantable device; storing configurationparameters in an implantable device, the stored configuration parametersbeing capable of controlling operation of the program; electronicallytransferring verification data between the implantable device and aprogramming device; verifying the configuration parameters are currentconfiguration parameters from a comparison of the transferredverification data with the stored data, wherein verifying configurationparameters includes verifying operational parameters that controltherapy provided by an implantable pacemaker are current.
 59. A method,comprising: storing a program in an implantable device; storingconfiguration parameters in an implantable device, the storedconfiguration parameters being capable of controlling operation of theprogram; electronically transferring verification data between theimplantable device and a programming device; verifying the configurationparameters are current configuration parameters from a comparison of thetransferred verification data with the stored data, wherein verifyingconfiguration parameters includes verifying configuration parametersthat control the therapy provided by an implantablecardioverter/defibrillator are current. 60-68. (Canceled)
 69. Aprogramming device for an implantable device, wherein the implantabledevice has configuration parameters that are used by a program tocontrol a therapy provided to a patient, wherein the programming devicecomprises: a user interface; a memory configured to store configurationparameters; a communications circuit configurable to communicate withthe implantable device; and a microprocessor coupled to the memory andthe user interface, and further coupled to the communications circuitadapted to retrieve configuration parameters from the implantable deviceand send configuration parameters to the implantable device; wherein thecommunication circuit is configured to electronically transferverification data between the implantable device and the programmingdevice, and the microprocessor compares the transferred verificationdata with stored data and verifies configuration parameters of theimplantable device are current configuration parameters from thecomparison of the transferred verification data with the stored data,and wherein the microprocessor verifies that the retrieved configurationparameters are current by retrieving the current configurationparameters from the implantable device and comparing the currentconfiguration parameters to the previously retrieved configurationparameters. 70-76. (Canceled)